CHOCO-CABANA Trial

Status Active, not recruiting

Clinical Trial Summary

The study will be performed 120 patients at about 6 to 8 study centers. Only patients with clinical conditions requiring assessment of patency of the treated BTK lesions at 6 months post procedure by MRA as part of standard care to prevent amputations as consequence of non-detected re-stenosis/occlusions will be included in the study. The sequence in which the individual patients will be treated will be randomized with the Chocolate PTA balloon and the uncoated conventional PTA balloon at each center. 60 patients will be randomized to uncoated conventional PTA balloon treatment and 60 patients to treatment with the Chocolate PTA balloon.

All lesions in each patient (lesions that fulfill the inclusion/exclusion criteria) should be treated as the patient is randomized.

In patients with long lesions more than one balloon may be used. Overlapping of balloons (at least 10mm) is mandatory to avoid untreated gaps between sequential treatments. Follow up will be performed at 1 and 6 months.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Atherosclerosis

Clinical Trial Details

NCT number	NCT04539145
Study type	Interventional
Source	Klinikum Rosenheim
Contact
Status	Active, not recruiting
Phase	Phase 4
Start date	August 4, 2020
Completion date	March 27, 2022

View Details

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